Treatment with IL-13 cytokine inhibitor tralokinumab was associated with significant long-term improvements in symptoms related to moderate to severe atopic dermatitis (AD) over 2 years, according to study results presented at the American Academy of Dermatology’s Virtual Meeting Experience (AAD VMX) 2021, held online from April 23 to April 25, 2021.
The study findings were from an interim analysis of the ongoing, 268-week open-label extension trial ECZTEND, which enrolled patients with moderate to severe AD who participated in the ECZTRA 1, 2, 3, and 5 parent trials. The interim analysis was performed at 56 weeks, but patients enrolled in the open-label trial had been treated with 300 mg tralokinumab every other week with optional topical corticosteroids.
The researchers evaluated interim efficacy at week 56 using the Investigator Global Assessment (IGA) score of clear or almost clear skin (IGA 0/1) and 75% or greater improvement in the Eczema Area and Severity Index score (EASI-75).
A total of 1174 patients were included in the interim analysis at time of data cut-off. At week 56, the investigators analyzed observed outcomes for 513 patients who were enrolled 60 weeks before the data cut-off.
The observed EASI response rates for the patients who completed 52 weeks of tralokinumab treatment in parent trials ECZTRA 1 and 2 and 56 weeks or longer in ECZTEND (n=291) were 93.8% (EASI-50), 82.5% (EASI-75), and 59.8% (EASI-90). These findings, according to the investigators, demonstrate that treatment with tralokinumab is associated with “sustained efficacy” in AD.
Approximately 11.8% of patients withdrew from the study; rates of discontinuation due to an adverse event (AE) were relatively low (1.6%), the researchers noted. It was found that as many as 71.9% of patients in the safety analysis set (n=1174) experienced an AE. Most of the AEs were mild to moderate. The most common AEs were viral upper respiratory tract infection (21.3%), AD (13.5%), and upper respiratory tract infection (7.1%).
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LEO Pharma presents long-term safety and efficacy data for tralokinumab in adults with moderate-to-severe atopic dermatitis at AAD VMX 2021. Press release. April 23, 2021. https://www.businesswire.com/news/home/20210423005376/en/LEO-Pharma-Presents-Long-Term-Safety-and-Efficacy-Data-for-Tralokinumab-in-Adults-With-Moderate-to-Severe-Atopic-Dermatitis-at-AAD-VMX-2021